NCT00315029

Brief Summary

Background: The number of multiple pregnancies is considered to be the most important adverse effect of in vitro fertilisation (IVF) and intracytoplasmic sperm injection (ICSI). IVF or ICSI with transferring only one embryo, elective single embryo transfer (eSET), will reduce this incidence remarkably. Unfortunately, former research has documented that cycles with SET maintain lower pregnancy rates compared to double embryo transfer (DET). Implementation of eSET will require a carefully chosen and thoroughly defined implementation strategy focussed on the couple undergoing the subfertility treatment. This trial will investigate the (cost)effectiveness of a combined patient centred implementation strategy. Objective: The main aim is to compare the effectiveness and costs of implementation of elective single embryo transfer (eSET) in in vitro fertilisation (IVF) and intracytoplasmic sperm injection (ICSI), between usual care and a combined patient-centred strategy. Study design: A randomised controlled trial Study population: Couples with a female age less than 40 years ongoing an IVF/ICSI treatment in 2 of the 13 Dutch IVF centres and their 4 satellite/transport centres. Intervention A combined patient centred implementation strategy for eSET in IVF/ICSI. The strategy consists of counselling through an evidence based decision aid and reimbursement of a 4th cycle if couples have chosen for eSET in the first 2 cycles. Primary study parameters/outcome of the study: the eSET occurrence rate, pregnancy outcomes and cost-effectiveness of the combined strategy. Secondary study parameters/outcome of the study:

  • patient knowledge
  • patient decisional conflict
  • patient satisfaction
  • IVF/ICSI treatment outcome.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
230

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2006

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 17, 2006

Completed
7 months until next milestone

Study Start

First participant enrolled

November 1, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

October 27, 2008

Status Verified

October 1, 2008

Enrollment Period

1.8 years

First QC Date

April 14, 2006

Last Update Submit

October 24, 2008

Conditions

Male InfertilityFemale InfertilityPregnancy

Keywords

ImplementationSingle embryo transferICSIIVFprevention

Outcome Measures

Primary Outcomes (1)

  • Incidence choice for eSET

    after embryo transfer

Secondary Outcomes (5)

  • Patient knowledge

    during treatment

  • patient decisional conflict

    during treatment

  • Patient experiences

    duringg treatment

  • Pregnancy outcomes

    after treatment

  • Cost-effectiveness

    after follow up

Study Arms (2)

1

EXPERIMENTAL

Receives combined patient centred intervention

Behavioral: evidence based decision aidBehavioral: Possible reimbursement 4th IVF/ICSI cycle when necessary

2

NO INTERVENTION

Standard treatment

Interventions

evidence based decision aidBEHAVIORAL

evidence based decision aid

1
Possible reimbursement 4th IVF/ICSI cycle when necessaryBEHAVIORAL

Potential reimbursement 4th IVF/ICSI cycle when necessary

1

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Female age \< 39 years
  • In first cycle minimum of two embryos available for transfer

You may not qualify if:

  • Medical necessity for single embryo transfer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Catharina ziekenhuis Eindhoven

Eindhoven, Netherlands

Location

Radboud University Nijmegen Medical Centre

Nijmegen, 6500HB, Netherlands

Location

Related Publications (5)

  • Pandian Z, Templeton A, Serour G, Bhattacharya S. Number of embryos for transfer after IVF and ICSI: a Cochrane review. Hum Reprod. 2005 Oct;20(10):2681-7. doi: 10.1093/humrep/dei153.

    PMID: 16183994BACKGROUND

  • Lukassen HG, Braat DD, Wetzels AM, Zielhuis GA, Adang EM, Scheenjes E, Kremer JA. Two cycles with single embryo transfer versus one cycle with double embryo transfer: a randomized controlled trial. Hum Reprod. 2005 Mar;20(3):702-8. doi: 10.1093/humrep/deh672. Epub 2004 Dec 23.

    PMID: 15618254BACKGROUND

  • Lukassen HG, Schonbeck Y, Adang EM, Braat DD, Zielhuis GA, Kremer JA. Cost analysis of singleton versus twin pregnancies after in vitro fertilization. Fertil Steril. 2004 May;81(5):1240-6. doi: 10.1016/j.fertnstert.2003.10.029.

    PMID: 15136084BACKGROUND

  • Brabers AE, van Dijk L, Groenewegen PP, van Peperstraten AM, de Jong JD. Does a strategy to promote shared decision-making reduce medical practice variation in the choice of either single or double embryo transfer after in vitro fertilisation? A secondary analysis of a randomised controlled trial. BMJ Open. 2016 May 6;6(5):e010894. doi: 10.1136/bmjopen-2015-010894.

    PMID: 27154481DERIVED

  • van Peperstraten A, Nelen W, Grol R, Zielhuis G, Adang E, Stalmeier P, Hermens R, Kremer J. The effect of a multifaceted empowerment strategy on decision making about the number of embryos transferred in in vitro fertilisation: randomised controlled trial. BMJ. 2010 Sep 30;341:c2501. doi: 10.1136/bmj.c2501.

    PMID: 20884700DERIVED

MeSH Terms

Conditions

Infertility, MaleInfertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy Complications

Study Officials

  • Rosella P Hermens, PhD

    Centre for Quality of Care Research (WOK), Radboud University Nijmegen Medical Centre

    PRINCIPAL INVESTIGATOR

  • Jan AM Kremer, MD, PhD

    Department of Obstetrics & Gynaecology, Radboud University Nijmegen Medical Centre

    PRINCIPAL INVESTIGATOR

  • Didi D Braat, Prof. MD PhD

    Department of Obstetrics and Gynaecology, Radboud University Nijmegen Medical Centre

    STUDY CHAIR

  • Richard PT Grol, Prof. PhD

    Centre for Quality of Care Research (WOK), Radboud University Nijmegen Medical Centre

    STUDY CHAIR

  • Willianne Nelen, MD, PhD

    Department of Obstetrics & Gynaecology, Radboud University Nijmegen Medical Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 14, 2006

First Posted

April 17, 2006

Study Start

November 1, 2006

Primary Completion

September 1, 2008

Study Completion

October 1, 2008

Last Updated

October 27, 2008

Record last verified: 2008-10

Locations

NL(2)